烟酸缓释胶囊在Beagle犬体内的药动学及生物等效性 |
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引用本文: | 王宇成,尹莉芳,陈金脱,陈西敬,周建平. 烟酸缓释胶囊在Beagle犬体内的药动学及生物等效性[J]. 安徽医药, 2012, 16(8): 1058-1060 |
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作者姓名: | 王宇成 尹莉芳 陈金脱 陈西敬 周建平 |
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作者单位: | 中国药科大学药学院,江苏,南京,210009 |
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基金项目: | 2008年度教育部新世纪优秀人才支持计划,"重大新药创制"科技重大专项新制剂与新释药系统技术平台,中央高校基本科研业务费专项基金 |
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摘 要: | 目的 6只Beagle犬双周期双交叉单剂量口服烟酸受试制剂和参比制剂。方法用LC-MS/MS法检测血浆中药物浓度,计算两种制剂的药动学参数并进行等效性评价。结果受试胶囊和参比片剂的主要药动学参数为:Tmax(3.00±0.80)和(3.08±0.90)h,Cmax(5.13±0.52)和(4.85±0.64)mg·L-1,AUC0-t(43.85±7.41)和(51.30±6.50)mg·L-1.h-1,AUC0-∞(47.25±5.35)和(49.19±4.21)mg·L-1.h-1。受试制剂的相对生物利用度F为(96.0±6.7)%。结论表明两种制剂生物等效。
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关 键 词: | 烟酸 缓释胶囊 药动学 生物等效性 |
Pharmacokinetics and bioequivalence of nicotinic acid sustained-release capsules in beagle dogs |
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Affiliation: | WANG Yu-cheng,YIN Li-fang,CHEN Jin-tuo,et al(Department of Pharmacy,China Pharmaceutical University,Nanjing 210009,China) |
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Abstract: | Objective To investigate the pharmacokinetics and bioequivalence of two nicotinic acid preparations in 6 Beagle dogs after oral administration.Methods The drug concentration in plasma was determined by LC-MS/MS.Results The pharmacokinetic parameters of the test capsules and reference tablets were as follows:Tmax(3.00±0.80) and(3.08±0.90) h,Cmax(5.13±0.52) and(4.85±0.64)mg·L-1,AUC0-t(43.85±7.41) and(51.30±6.50)mg·L-1·h-1,AUC0-∞(47.25±5.35) and(49.19±4.21)mg·L-1·h-1.The relative bioavailability of test preparation was(96.0±6.7)%.Conclusion The test and reference preparations were bioequivalent. |
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Keywords: | nicotinic acid sustained release capsule pharmacokinetics bioequivalence |
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